CDISC malaria standards available for your input

What are the CDISC standards, and why are they important?

Data sharing has become an essential part of clinical research as well as a prerequisite for an increasing number of journals, research funders and medicine regulatory agencies. One critical area of data sharing is the standardisation of clinical trial data. Standardisation can improve clinical research through increased data quality, and facilitates data integration and reusability, but standardisation can be a very complicated if done retrospectively.

The Clinical Data Interchange Standards Consortium, also known as CDISC, undertakes the immense task of developing ‘a common language for clinical research’ by establishing standards that support the acquisition, exchange, submission and archiving of clinical data. CDISC standards were not available for malaria until now.

How was the malaria standard developed?

With the increase in resistance to ACTs (artemisinin combination therapies), the World Health Organisation’s (WHO) recognised the urgency of new treatments for uncomplicated P. falciparum malaria, and the need for the development and registration of new antimalarial medicines. Recently, the US Food & Drug Administration announced that data submitted for possible registration from clinical trials starting after mid-December 2016 will need to conform to the CDISC standards from 2017. The Japanese Medicines Authority (PMDA) began requiring electronic data submissions in CDISC standard format beginning 01 October 2016, and the European Medicine Authority (EMA) has also considered the adoption of the CDISC global data standards.

WWARN was instrumental in initiating the proposed development of the first malaria data standard and submitted a formal proposal to CDISC in December 2014. Led by the University of Cape Town’s Prof Karen Barnes, Heads of WWARN’s Pharmacology Group, and Lesley Workman, WWARN’s Pharmacology Coordinator, the team facilitated input from across our network of partners. The review groups - comprised of malaria researchers involved in clinical trials - gathered via teleconference in early 2015 and again in person at the ASTMH Conference in Philadelphia, USA. Further progress continued through quarterly group updates and review cycles as the malaria standards went through each major iteration.

How can you get involved?

Active participation in the public review process for the malaria standard is essential to ensure the optimal, most relevant standard possible. We urge all involved in malaria studies and / or malaria clinical trials to use this opportunity to comment on the new CDISC Malaria Therapeutic Area User Guide (TAUG-Malaria). This document will provide much-needed guidance for malaria researchers, especially those involved in clinical trials in uncomplicated p. falciparum malaria.

To review and include your comments on the current TAUG-malaria you will need to log in or register for the CDISC Wiki.

1. To register for the Wiki: Register (JIRA and Wiki use the same login; please create only one login).

2. Instructions for providing comments: Instructions for Reviewers

3. You are encouraged to suggest additional elements that would be helpful in future versions of the TAUG-Malaria, which might include severe p. falciparum malaria and p. vivax malaria.

Deadline for input: Sunday, 6th of November 2016

Who to contact with your questions?

For questions regarding login or registration for the Wiki, please contact Alana St. Clair astclair@cdisc.org

For questions regarding the Case Record Form (CRF), or TAUG-Malaria, contact Lesley Workman lesley.workman@wwarn.org